NCT02115607

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Definity infusion	3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-05-23
• Completion: 2018-05-23
• First posted: 2014-04-16
• Last updated: 2025-05-06
• Results posted: 2019-10-31

Locations

1 site across 1 country: United States